Oral paracetamol versus oral ibuprofen for treatment of patent ductus arteriosus

Abstract

ObjectiveThis study was performed to investigate the safety and efficacy of oral paracetamol versus oral ibuprofen in the treatment of patent ductus arteriosus (PDA) in premature infants.MethodsPremature infants with PDA with a gestational age of ≤32 weeks or birth weight of ≤1500 g were included in this randomized study.ResultsA total of 120 premature infants fulfilled the inclusion criteria. Of these 120 infants, 34 fulfilled the treatment criteria and 22 were finally randomized. We found no significant difference in the mortality or primary closure rates between the two groups. We also found no significant difference in the short-term neonatal outcomes.ConclusionsEither oral paracetamol or oral ibuprofen can be used safely and effectively to treat PDA in premature infants.

Efficacy and Safety of Paracetamol for Patent Ductus Arteriosus Closure in Preterm Infants: An Updated Systematic Review and Meta-Analysis

“…This difference may allow POX inhibition to be optimally effective under conditions of low COX inhibitory activity (20). To date, although a number of correlative randomized controlled trials (RCTs) have compared the therapeutic efficacies of paracetamol and other drugs for PDA closure, most achieved insignificant results (21)(22)(23)(24)(25). Paracetamol's efficacy and safety for PDA closure in premature or low-birth-weight infants (or both) have not been fully determined.…”

Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol

“…Rate of ductus closure was 100%, with no adverse events reported. In subsequent years, additional case series and clinical trials evaluating this new treatment option have been published (7,(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30). Table 1 summarizes the existing randomized clinical trials (RCTs) comparing paracetamol to standard treatment.…”

Pharmacological treatment strategies for neonates with patent ductus arteriosus: a systematic review

“…A summary of the studies' designs are compiled in Table 3. 8,[11][12][13][14][15][16] Outcomes from all studies were similar in that paracetamol was equally effective in closing PDA as compared to ibuprofen or indomethacin. Adverse effects observed varied from study to study.…”

“…In the studies by Oncel et al, 13 Al-Lawama et al, 14 and Dash et al, 15 paracetamol was associated with a similar rate of adverse reactions as ibuprofen and indomethacin. In contrast, Bagheri et al, 8 Balachander et al, 11 Dang et al, 12 and El-Mashad et al 16 reported the relative safety of paracetamol, in that it was associated with significantly lower rates of various adverse events such as acute kidney injury, thrombocytopenia, hyperbilirubinemia, gastrointestinal bleeding, liver or renal dysfunction, intraventricular haemorrhage, and retinopathy of prematurity.…”

“…The trials by Bagheri et al, 8 Balachander et al, 11 Dang et al, 12 and El-Mashad et al 16 associated paracetamol with less adverse reactions compared to ibuprofen and indomethacin, including hyperbilirubinemia, acute kidney injury, renal dysfunction, thrombocytopenia and gastrointestinal bleeding The other studies demonstrated similar rates of adverse reactions between paracetamol and ibuprofen or indomethacin ( Table 3). [13][14][15] To assess the quality of the selected studies, a critical appraisal tool from Oxford CEBM was used. 10 Overall, the studies appeared to have good quality, with slight variations in attempts at blinding and intention-to-treat analyses.…”